DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed 07/21/2025 have been fully considered but are not persuasive.
Applicant argues, “Leavitt fails to disclose calculating a relative angle between the two sensors. On page 10 of the Non-Final Office Action, the Examiner asserts that Leavitt discloses calculating a relative angle between two sensors in Figure 9B. Specifically the Examiner asserts the claimed "relative angle between the two sensors" is the "joint flexion angle 983 which is calculated by subtracting 981 from 982." The Applicant respectfully submits that a person having ordinary skill in the art would understand the flexion angle as the decrease in the angle between two bones connected at that joint, usually due to the movement of muscles contracting. In other words, the Applicant respectfully submits that the flexion angle is not the relative angle between the two sensors, as expressly required in claims 1 and 18.”
Examiner respectfully disagrees. Under broadest reasonable interpretation, the limitation “a relative angle between the pair of sensors” is interpreted as an angle relative to the pair of sensors. Therefore, the joint flexion angle 983 of Leavitt, under broadest reasonable interpretation, reads on “a relative angle between the pair of sensors”.
Applicant argues, “Moreover, Leavitt discloses using "prolonged absence of motion" as an indicator for the wearable joint rehabilitation device not being worn by the patient (see par. [0095] of Leavitt). Thus, when confronted with the objective technical problem, the skilled person might have considered determining that the wearable joint rehabilitation device is not being worn by the patient based on (a) the relative orientations detected by the wearable joint rehabilitation device and (b) prolonged absence of motion. According to Leavitt, the joint angle is determined based on spatial rehabilitation data in step 665, which requires the sampling of data in preceding step 645. This data is sampled in step 645 after it has been determined that the device is worn by the patient in step 640.
That is, the joint angle is only determined if the device is worn by the patient (see pars. [0095]- [0099] of Leavitt). Still further, the joint angle mentioned in Leavitt is not considered in any subsequent determination related to placement of the wearable joint rehabilitation device, as expressly required in claims 1 and 18. Rather, the joint angle is used as an indicator of a range of motion of the joint if the device is worn by the patient (see par. [0099] of Leavitt).”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the determination is made while the device is not worn) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regards to Applicant’s argument that the joint angle is not considered in any subsequent determination related to placement of the wearable joint rehabilitation device, Examiner respectfully states that the limitation “determining based on at least one of the calculated relative angle and the calculated joint angle whether either or both of the sensors is not mounted”, under broadest reasonable interpretation, only requires that at least one of the calculated relative angle and the calculated joint angle are used at some point in the process to determine whether either or both of the sensors are mounted. This is taught by Leavitt, which teaches using relative orientations and/or prolonged absence of motion [0094-0096] to determine whether the wearable joint rehabilitation device is being worn [0094-0095], and the relative orientations may be determined using the first and second inertial sensors [0147, 0025-0026, 0055].
Applicant argues, “The Applicant respectfully submits this combination of elements imposes meaningful limits in that the mathematical operations are applied to improve an existing technology (wearable sensors) by improving the data acquisition of the sensors due to the recognition that the sensors are in an unworn state, which eliminates the acquisition of data being collected that is not representative of the patient's motion. All of these features, especially when viewed in combination, amount to significantly more than the judicial exception (Step 2B). Thus, the Applicant respectfully submits that amended claim 1 is subject matter eligible under 35 USC 101”.
Examiner respectfully states that even if the invention improves data acquisition of the sensors, there is still nothing in the claims which integrate the judicial exception into a practical application. For instance, the limitation directed to “determining that the sensor system is in the unworn state” is understood as moving information around, and therefore falls under additional elements, specifically are insignificant extra solution activities. Therefore, none of the claims 1-20 amounts to significantly more than the abstract idea itself.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 1, the following limitations lack antecedent basis:
“the pitch and/or roll of the individual sensor”
“the relative pitch and/or roll between the sensors”.
In re claim 18, see in re claim 1 above.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In re claim 18: “a calculation unit.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1 and 18 recite a method for determining an unworn state of a sensor system recordings and a system for providing information about a joint. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1 and 18 recite the following claim limitations which are directed to mathematical concepts (see MPEP § 2106.04(a)(2), subsection I):
Claim 1:
“calculating a relative angle between the pair of sensors using one or more of the one or more measurements” (mathematical relationships, mathematical formulas or equations, and mathematical calculations)
“calculating, using one or more of the one or more measurements, a joint angle between the first and second body parts” (mathematical relationships, mathematical formulas or equations, and mathematical calculations)
In re claim 18, see in re claim 1 above.
These limitations, under their broadest reasonable interpretation, cover mathematical concepts. For instance, the relative angle and joint angle are calculated using measurements, which further implies that they are mathematical concepts, specifically mathematical calculations based on mathematical relationships and formulas. Therefore, since the claim limitations can be broken down into mathematical relationships, formulas or equations, and calculations, the claim limitations fall within the ‘mathematical concepts’ grouping of abstract ideas.
Additionally, claims 1-20 recite limitations directed toward a mental process.
Claim 1 recites: “determining….whether either or both of the sensors is not mounted and if so, determining that the sensor system is in the unworn state.”
This limitation is directed towards judgment and evaluation, and can be done in the human mind by a doctor determining whether or not sensors are mounted on the patient’s joint, and if they are not mounted, then determining that the sensor system in in the unworn state.
In re claim 18, see in re claim 1 above.
Therefore, each of the above identified claims recite an abstract idea.
Step 2A, Prong 2:
Claims 1 and 18 recite the following additional elements:
Claim 1:
“… a sensor system comprising a pair of sensors configured for mounting on first and second body parts either side of a joint,”
“with each sensor containing one or more motion sensing devices which permit either
{iI the pitch and/or roll of the individual sensor to be determined or
{iiI the relative pitch and/or roll between the sensors to be determined”,
“obtaining one or more measurements from each sensor,” and
“where the joint angle is defined in a plane of normal bending of the joint”
Claim 18:
“A first sensor unit configured to be mounted on a first body part on a first side of the joint,
the first sensor unit comprising:
one or more first sensors arranged to take one or more measurements relating to
the first body part and
one or more measurements relating to the one or more first sensors; and
a transmitter arranged to transmit taken measurements; and
a second master sensor unit configured to be mounted on a second body part on a second side of the joint,
the second master sensor unit comprising: one or more second sensors arranged to take
one or more measurements relating to the second body part and
one or more measurements relating to the one or more second sensors;
with each sensor containing one or more motion sensing devices which permit either
{iI the pitch and/or roll of the individual sensor to be determined or
{iiI the relative pitch and/or roll between the sensors to be determined,
a receiver arranged to receive the one or more measurements relating to
the first body part and
the one or more measurements relating to the one or more first sensors transmitted from the transmitter of the first sensor unit; and
a calculation unit
where the joint angle is defined in a plane of normal bending of the joint”.
The limitations above refer to using mathematical concepts to calculate a relative angle and a joint angle so that a determination can be made on whether or not the pair of sensors are mounted, and if so, then determining that the sensor system is in an unworn state. This step is post-solution activity since it provides a determination of whether or not the sensor system is in an unworn state based off of the relative angle and the joint angle.
Additionally, the above recited additional elements are insignificant extra solution activities. Specifically, using a pair of sensors to obtain measurements relating to the first and second body part is directed towards pre-solution activity since it collects measurements that will later be analyzed and calculated (i.e. mathematical calculations and outputs) relating to the joint angle and the relative angle.
Therefore, determine that the system is in an unworn state is merely data gathering in conjunction with mathematical concepts and the additional elements do not integrate a judicial exception into a practical application. Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and mere data gathering, mathematical calculations, and mathematical functions. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere data gathering combined with mathematical concepts. The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1-20 amounts to significantly more than the abstract idea itself. Accordingly, claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas which use mathematical concepts and mere data gathering as further discussed in the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP 2106.04(a)(2), and MPEP 2106.05(g).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 15-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Leavitt et al. (US 2019/0038225).
In re claim 1, Leavitt discloses
a method for determining an unworn state of a sensor system [0094-0095] comprising a pair of sensors (fig. 9A: inertial sensors 970 and 972; [0147]) configured for mounting on first ([0147]: sensor 970 corresponds to first body portion) and second body parts ([0147]: sensor 972 corresponds to second body portion) either side of a joint (fig. 9A: 970 and 972 on either side of joint 950; [0147]),
with each sensor containing one or more motion sensing devices ([0147]: sensors comprise an inertial sensor) which permit either
{iI the pitch and/or roll (fig. 9B) of the individual sensor to be determined (fig. 9B: pitch of the sensor is determined relative to the vertical reference 980, for instance angle 982 for the inertial sensor 972 and angle 981 for the inertial sensor 970; [0147-0148]) or
{iiI the relative pitch and/or roll (fig. 9B) between the sensors to be determined (fig. 9B: relative pitch between the sensors i.e. angle 983 is determined; [0147-0148]),
the method comprising:
obtaining one or more measurements from each sensor ([0096]: inertial data is used to sample “motion and/or position or orientation data” which is referred to as spatial rehabilitation data; [0094, 0147-0148]);
calculating a relative angle between the pair of sensors using one or more of the one or more measurements (fig. 9B: relative angle is joint flexion angle 983 which is calculated by subtracting 981 from 982; [0148]);
calculating, using one or more of the one or more measurements, a joint angle between the first and second body parts ([0099]: static angle resolution is determined from the spatial rehabilitation data which corresponds to joint angle),
where the joint angle is defined in a plane of normal bending of the joint ([0099]: static angle resolution provides a range of motion detection i.e. bending of the joint which would be in a plane of normal bending; [0148]): and
determining based on at least one of the calculated relative angle and the calculated joint angle whether either or both of the sensors is not mounted ([0094-0096]: relative orientations and/or prolonged absence of motion corresponds to the wearable joint rehabilitation device not being worn and orientations would include the calculated relative angle and the calculated joint angle) and
if so, determining that the sensor system is in the unworn state [0094].
In re claim 2, Leavitt discloses
wherein obtaining the one or more measurements from each of the pair of sensors is performed multiple times in a time period [0104-0106] and
the calculating the relative angle and the calculating the joint angle is performed using measurements obtained at least some of the multiple times (fig. 6: on-body-joint sensing 640 occurs multiple time due to the arrow which exits 640 and goes back to block 635; [0094]: adaptive delay sample rate control can be adjusted i.e. measurements are obtained multiple times),
the method comprising the further step of, following the determination that the sensor system is in the unworn state (see in re claim 1 above), adopting a different procedure with regard to calculating the joint angle at subsequent times ([0094]: adaptive delay sample rate set to a low-rate resting mode with longer periods between samples).
In re claim 3, Leavitt discloses wherein adopting the different procedure comprises any one or more of:
not calculating the joint angle at subsequent times ([0094]: adaptive delay sample rate may be set to a low-rate resting mode which means that the joint angle is not calculated as often as previously at subsequent times);
differently processing the calculated joint angles at subsequent times from those calculated at times prior to the determination; and
not storing the joint angles calculated at subsequent times.
In re claim 4, Leavitt discloses further comprising
correlating the joint angles and the relative angles calculated at multiple times to provide information about the joint over the time period ([0094]: relative orientations and detecting a prolonged absence of motion corresponds to information about the joint over a period of time; [0135-0140]: device can measure information about the joint over a period of time such as motion and improvement in daily activity), and
wherein adopting the different procedure comprises omitting any data calculated using measurements made at subsequent times from the information ([0094]: adaptive delay sample rate may be set to a low-rate resting mode which means omitting data made at subsequent times compared to if the adaptive delay sample rate was not in low-rate resting mode).
In re claim 5, Leavitt discloses wherein the information comprises any one or more of:
joint angle variation during the time period ([0094]: relative orientation provides information about joint angle variation depending on the adaptive delay sample rate control);
a duration of time in which the joint is active [0136, 0138];
a duration of time in which the joint is bearing a load;
a length of the time period; and
if the joint is a knee, a step count over the time period.
In re claim 6, Leavitt discloses
wherein adopting the different procedure comprises performing calculations to provide different information from the information about the joint ([0094]: adopting a different procedure i.e. a low-rate resting mode is based on calculations to determine a prolonged absence of motion and/or relative orientations detected),
wherein the different information includes any one or more of:
an unworn time ([0094]: prolonged absence of motion is detected); and
if the one of the pair of sensors is determined to be charging, a charging time.
In re claim 7, Leavitt discloses
wherein the pair of sensors includes a first sensor and a second sensor (see in re claim 1 above),
wherein the unworn state includes any one or more of:
the first sensor having been at least partially removed from its mounted position ([0094]: if the wearable joint rehabilitation device is not being worn at all then the first sensor will be at least partially removed from its mounted position);
the first sensor falling off its mounted position at least to some extent;
the first sensor being switched on but not mounted on the first body part; and
the second sensor being switched on but not mounted on the second body part.
In re claim 8, Leavitt discloses wherein determining whether either or both of the pair of sensors are mounted on the first or second body parts based on a value of a function of at least one of the calculated relative angle and the calculated joint angle ([0094-0096]: spatial rehabilitation data i.e. calculated joint angle and calculated relative angle from the sensor data which provides position information is used to determine if the wearable harness is worn; [0136]: sensor data provides data on motion; [0029, 0099]; [0094-0095]: relative orientations and/or prolonged absence of motion used to determine if both of the sensors are being worn).
In re claim 15, Leavitt discloses further comprising
wherein the pair of sensors includes a first sensor and a second sensor (see in re claim 1 above),
the method further comprising,
prior to the obtaining, determining whether the first sensor and the second sensor are mounted
on correct respective first and second body parts and/or
in substantially a predetermined orientation relative to the correct respective first and second body parts ([0093]: healthcare provider may instruct a patient to position the joint in selected positions or orientation while the wearable joint rehabilitation device is mounted on the first and second body parts), and
if one or both sensors is determined to be mounted on a wrong body part or in a different orientation from the predetermined orientation ([0094]: detection that there is a prolonged absence of motion that corresponds to the wearable joint rehabilitation device not being worn i.e. the sensors are in a different orientation from the predetermined orientation, such as from the are not being worn), adjusting the calculating steps to take account of an actual determined mounting
location and/or
orientation ([0094]: upon detecting prolonged absence of motion, it’s determined that the mounting orientation is of the wearable joint rehabilitation device not being worn, which adjusts the delay sample rate between sample acquisitions).
In re claim 16, Leavitt discloses wherein the pair of sensors includes a first sensor and a second sensor, the method further comprising, prior to the obtaining (fig. 6: prior to 640), calibrating the first sensor and the second sensor (630; [0093]) with respect to a predetermined orientation relative to the respective first and second body parts [0093].
In re claim 17, Leavitt discloses wherein the joint is a knee (fig. 2A) or an elbow (fig. 2B).
In re claim 18, Leavitt discloses a system for providing information about a joint (fig. 2A: 250; inertial sensors 970 and 972 shown in fig. 9A can be used in the wearable harness show in in fig. 2A [0014, 0025]; [0094-0095]), comprising:
a first sensor unit (fig. 2A: smart buckle 265; [0062]) configured to be mounted on a first body part (fig. 2A: smart buckle 265 located on upper leg) on a first side of the joint (fig. 2A),
the first sensor unit comprising:
one or more first sensors (fig. 4: 405; [0072]: integrated components within a smart buckle) arranged to take one or more measurements relating to
the first body part ([0096]: inertial data is used to sample “motion and/or position or orientation data” which is referred to as spatial rehabilitation data; [0094, 0147-0148]) and
one or more measurements relating to the one or more first sensors [0075-0076]; and
a transmitter arranged to transmit taken measurements (fig. 4: 420); and
a second master sensor unit (254) configured to be mounted on a second body part (fig. 2A: smart buckle 254 located on lower leg) on a second side of the joint (fig. 2A),
the second master sensor unit comprising:
one or more second sensors (fig. 4A: 446; [0076]: second inertial sensor) arranged to take one or more measurements relating to
the second body part [0075-0076, 0094] and
one or more measurements relating to the one or more second sensors [0075-0076];
with each sensor containing one or more motion sensing devices (see in re claim 1 above) which permit either
{i} the pitch and/or roll of the individual sensor to be determined (see in re claim 1 above) or
{ii} the relative pitch and/or roll between the sensors to be determined (see in re claim 1 above),
a receiver ([0076]: part of processor 425 which receives information on first and second inertial sensor data) arranged to receive the one or more measurements relating to
the first body part [0076-0077] and
the one or more measurements relating to the one or more first sensors transmitted from the transmitter of the first sensor unit [0076-0077]; and
a calculation unit ([0097]: part of on-device data processing which processes spatial rehabilitation data; [0076]: processor 425) configured to calculate, using one or more of the measurements [0075-0077, 0148],
a relative angle between the first sensor unit and the second master sensor unit (see in re claim 1 above) and
a joint angle between the first and second body parts (see in re claim 1 above),
where the joint angle is defined in a plane of normal bending of the joint (see in re claim 1 above),
the calculation unit being further configured to determine, based on the calculated relative angle and the calculated joint angle ([0094-0096]: spatial rehabilitation data i.e. calculated joint angle, calculated relative angle from sensor data which provides position information, and relative orientations which includes the calculated relative angle and the calculated joint angle are used to determine if the wearable harness is worn; [0136]: sensor data provides data on motion; [0029, 0099]), whether either or both of the first sensor unit and the second master sensor unit are not mounted [0094-0095] and
if so, determine that the system is in an unworn state [0094].
In re claim 19, regarding the limitation, “wherein the first sensor unit and the second master sensor unit are configured to take measurements multiple times in a time period and the calculation unit is configured to calculate the relative angle and a joint angle using measurements obtained at each of at least some of the multiple times, the calculation unit being further configured to, following a determination that the system is in the unworn state, adopt a different procedure with regard to calculating the joint angle at subsequent times,” see in re claim 2 above.
In re claim 20, regarding the limitation, “wherein the calculation unit is further configured to correlate the joint angles and the relative angles calculated at multiple times to provide information about the joint over the time period, and wherein adopting the different procedure comprises omitting any data relating to measurements made at subsequent times from the information,” see in re claim 4 above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Galiana Bujanda et al. (US 2021/0007874).
In re claim 9, Leavitt discloses further comprising
processing multiple calculated values of the function over a time period to determine a range-of-motion value for the function ([0099]: max and min joint angles reached within a period of time are used to calculate a range-of-motion; [0101, 0105]) and
wherein the determining further comprises comparing the determined range-of-motion value to a threshold value ([0133]: range of motion is compared with a threshold value i.e. expected progress and provides an indication of there are deviations).
Leavitt fails to disclose further comprising
processing multiple calculated values of the function over a time period to determine a moving average value for the function and
wherein the determining further comprises comparing the determined moving average value to a threshold value.
Galiana Bujanda teaches an wearable device [0007] that actuates movement about a joint of a wearer [0007], and teaches
processing multiple calculated values of a function over a time period ([0473]: joint angles of a hip are measured over time to calculate an average angle to determine if the hip is moving up or down based on a change in the average angle; [0431]) to determine a moving average value for the function ([0473]: moving average is the change in the average angle of the hip joints; [0431]) and
wherein a determining of a transition to a moving up state or a moving down state [0473] further comprises comparing the determined moving average value to a threshold value ([0431]: threshold used to indicate the start of the lifting motion or crouching pose to be assisted; [0473]).
Galiana Bujanda further teaches that the average angle of the hip joints changing about seven degrees from a neutral angle of the joints can indicate a change in movement [0473, 0536].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system taught by Leavitt, to provide processing multiple calculated values of the function over a time period to determine a moving average value for the function and wherein the determining further comprises comparing the determined moving average value to a threshold value, as taught by Galiana Bujanda, because comparing the change in average joint angle with a threshold allows for the detection of movement in the joint angle, which will allow Leavitt to further detect if the wearable device is being worn.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Lucas et al. (US 2015/0022362).
In re claim 10, Leavitt fails to disclose wherein the function comprises a function of
a joint angle penalty and
a relative angle penalty.
Lucas teaches a wearable device (fig. 1: 100) that detects improper movements at a body joint [0001]
which monitors
a joint angle ([0043]: joint angle is bend angle formed on a transverse axis by first bone 30 relative to second bone 10; fig. 1) and
a relative angle ([0043]: relative angle is formed on a lateral axis by a horizontal displacement of the first bone 30 relative to the second bone 10; fig. 1), and
wherein a function ([0043]: threshold comprises the bend angle and the lateral angle) comprises a function of
a joint angle penalty ([0060]: whether the first bend angle exceeds a threshold; [0022-0023]) and
a relative angle penalty ([0060]: whether the first lateral angle exceeds a threshold; [0022-0023]).
Lucas further teaches that a signal can be generated to indicate that the knee has made an improper movement depending on the threshold being exceeded [0025], and allows for feedback to be generated [0025].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system taught by Leavitt, to provide wherein the function comprises a function of a joint angle penalty and a relative angle penalty, as taught by Lucas, because doing so provides an indication for improper movement of a joint and then generates feedback.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Lucas et al. (US 2015/0022362) in view of Kang (US 2019/0066832).
In re claim 11, the proposed combination fails to yield wherein
if the joint angle is within a feasible range for the joint, the joint angle penalty is zero and
if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is.
Kang teaches a method for detecting patient risk during physical therapy [0008], and teaches wherein
if a joint angle ([0086]: joint angle is measured range of motion in a degree of freedom in a joint of interest) is within a feasible range for a joint ([0086]: if the measured range of motion is within a target range of motion), a joint angle penalty is zero ([0086-0087]: risk score is the magnitude of differences between the actual ranges of motion and the target ranges of motion in each specified degree of freedom, therefore, the risk score is zero when the measured range of motion is within the target range of motion) and
if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is ([0086-0087]: risk score is the magnitude of differences between the actual ranges of motion and the target ranges of motion in each specified degree of freedom, therefore the risk score will depend on how far outside the feasible range the joint angle is).
Kang further teaches that if the risk score exceeds a threshold score [0013], then the patient can be flagged for care provider review [0087], so that the care provider can intervene in the patient’s recovery [0085].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor yielded by the proposed combination, to provide wherein if the joint angle is within a feasible range for the joint, the joint angle penalty is zero and if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is, as taught by Kang, because although the risk score in Kang shows how risky the angle may be based on how high it is, Leavitt would instead use this to show how unlikely it is that the wearable device is actually being worn (i.e. the higher risk score in Kang would indicate the risk of injury, while the higher score in Leavitt would indicate how unlikely it is that the user is actually wearing the sensor based on how far outside the joint angle is from the feasible range).
In re claim 12, the proposed combination yields discloses wherein if the relative angle is less than or equal to a threshold relative value (Lucas: [0022]: if the first lateral angle is less than an inward lateral angle associated with the bend angle of the threshold), the relative angle penalty is zero (Lucas: [0022]: threshold is not exceeded if the first lateral angle is less than the inward lateral angle i.e. the relative angle penalty would be 0).
The proposed combination fails to yield wherein if the relative angle penalty is greater than the threshold relative value, the relative angle penalty depends on how much greater the relative angle is than the threshold relative value.
Kang teaches wherein if a relative angle penalty ([0086]: relative angle penalty is a measured range of motion in a different degree of freedom from the joint angle discussed in re claim 11 above) is greater than a threshold relative value, the relative angle penalty depends on how much greater the relative angle is than the threshold relative value ([0086-0087]: relative angle penalty i.e. the risk score is the magnitude of difference of the actual ranges of motion in the specified degree of freedom in the joint corresponding to the target ranges of motion).
For substantially the same reasons as discussed in re claim 11 above, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor yielded by the proposed combination, to provide wherein if the joint angle is within a feasible range for the joint, the joint angle penalty is zero and if the joint angle is not within the feasible range for the joint, the joint angle penalty has a value which depends on how far outside the feasible range the joint angle is, as taught by Kang, because the relative angle penalty can be used to determine if the risk score exceeds a certain threshold so that a care provider can provide intervention to the patient.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Leavitt et al. (US 2019/0038225) in view of Heijkants et al. (US 2010/0286950).
In re claim 13, Leavitt discloses wherein the relative angle is a difference in a tilt angle of the first body part and the second body part (fig. 9B: angle 983 is calculated based on a tilt angle of the first body part i.e. angle 982 minus the tilt angle of the second body part i.e. angle 981).
Leavitt fails to disclose
where tilting occurs about an axis perpendicular or substantially perpendicular to the plane in which the joint angle is defined.
Heijkants teaches a method [0001] of measuring a joint angle (fig. 1: alpha) between a first member (1) and a second member (2), where tilting occurs about an axis perpendicular or substantially perpendicular to the plane in which the joint angle is defined (fig. 1: tilting occurs at an axis perpendicular to a plane where a joint angle is defined; [0042]).
Heijkants further teaches that any kind of angle differences in a plane perpendicular to an axis may be measured [0042], and that other angles may be measured in a similar way [0042].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for determining an unworn state of a sensor system taught by Leavitt, to provide where tilting occurs about an axis perpendicular or substantially perpendicular to the plane in which the joint angle is defined, as taught by Heijkants, because any kind of angle differences in a plane perpendicular to an axis may be measured, and because other angles may be measured in a similar way.
In re claim 14, the proposed combination (all mapping directed to Leavitt unless otherwise stated) discloses wherein
the joint angle is defined in an x-z plane (fig. 2A: bending of the joint would be defined in the x-z plane i.e. horizontal and depth of the joint bending as detected by the wearable joint rehabilitation device; [0096]) and
the tilt angle is defined in an x-y plane and is non-zero if the first and second body parts undergo a relative roll about an x-axis (fig. 9B: tilt angle is calculated in an x-y plane and would be non-zero if the first and second body parts rotated around the x-axis during flexion or extension of the first and second body parts).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796